Medline DRAPE PACK-CHOICE recalled for potential sterility issue
Stop using Medline DRAPE PACK-CHOICE kits
Medline identified calibration problems in the equipment used to sterilize and package DRAPE PACK-CHOICE kits (Model DYNJ63118A). While the products went through sterilization cycles, the equipment calibration issues may have affected whether the products are properly sterile.
- Stop using DRAPE PACK-CHOICE kits with Lot Number 25ABV005
- Check your inventory for Model DYNJ63118A and this lot number
- Contact Medline or your supplier for instructions on return or replacement
- Do not use recalled kits on patients
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1406-2026More Medline Industries, LP recalls
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